Vivid S60N and S70N User Manual Ver 203 Rev 12 Feb 2020

Regulatory requirement This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices.

0123 This manual is a reference for the Vivid S70N and Vivid S60N ultrasound systems and covers the following models: Vivid S70N v203 and Vivid S60N v203. It applies to all revisions of the 203 software for the Vivid S70N and Vivid S60N ultrasound systems, which will hereafter be listed as Vivid S70N / S60N. All information in this manual is relevant for the two systems unless otherwise specified.

GE Vingmed Ultrasound AS Strandpromenaden 45 3191 Horten, Norway Tel:(+47) 3302 1100 Fax: (+47) 3302 1350 www.gehealthcare.com

Revision History Reason for change

REV

DATE (YYYY-MM-DD)

REASON FOR CHANGE

Rev. 01

2018-04-12

Initial draft

Rev. 02

2018-05-29

ME version

Rev. 03

2018-06-06

Revised draft

Rev. 04

2018-07-30

Revised draft

Rev. 05

2018-08-17

M3 version

Rev. 06

2018-10-03

Probe presets & Care and Maintenance Data streaming Wireless Network Configuration Biological Hazard

Rev. 07

2018-10-23

System Care and Maintenance Probe Care and Maintenance

Rev. 08

2018-10-25

Contact Information Electromagnetic Compatibility (EMC) Device labels Connect and disconnect probes

Rev. 09

2018-12-05

Tricefy

Rev. 10

2019-01-18

Probe applications/indications table Contact Information

Rev. 11

2019-11-28

Probe applications/indications table Probe presets

Rev. 12

2020-02-27

Importer Information

List of Effective Pages PAGE NUMBER All pages

REV Rev. 12

Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE electronic Product Data Management). If you need to know the latest revision, contact your distributor, local GE

Vivid S70N / S60N – User Manual FR092760-1EN 12

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Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.

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Vivid S70N / S60N – User Manual FR092760-1EN 12

Regulatory Requirements

Conformance Standards The GE Healthcare product families are tested to meet all applicable requirements and relevant standards per the countries in which the product will be sold. Any changes to accessories, peripheral units, or any other part of the system must be approved by the manufacturer: GE Vingmed Ultrasound AS. Ignoring this advice may compromise the regulatory approvals obtained for the product. This product complies with the regulatory requirements of the following: Standard/Directive

Scope

93/42/EEC

Medical Devices Directive (MDD)

2012/19/EU

Waste Electrical and Electronic Equipment (WEEE)

2011/65/EU

Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (ROHS)

IEC/EN 60601-1 ANSI/AAMI ES60601-1 CAN/CSA-C22.2 No. 60601-1

Medical Electrical Equipment - Part 1. General requirements for basic Safety and essential performance

IEC/EN 60601-2-37

Medical electrical equipment - Part 2-37. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

IEC/EN 60601-1-2

Medical Electrical Equipment - Part 1-2. General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

IEC/EN 60601-1-6

Medical Electrical Equipment - Part 1-6. General requirements for basic safety and essential performance - Collateral standard: Usability

NEMA/AIUM UD-3

Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment.

IEC/EN 62304

Medical Device Software - Software life-cycle processes

IEC/EN 62366

Medical Devices - Application of usability engineering to medical devices

ISO 10993-1

Biological evaluation of medical devices

Vivid S70N / S60N – User Manual FR092760-1EN 12

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Certifications •

GE Vingmed Ultrasound AS, Horten is ISO 13485 certified.

•

GE Vingmed Ultrasound AS, China is ISO 13485 certified.

Importer Information •

TURKEY Türkiye İthalatçısı / Turkish Importer

•

GE Medical Systems Türkiye Ltd. Şti. Esentepe Mah. Harman Sok. No: 8 34394 Şişli İstanbul Türkiye

BRAZIL NOME DO IMPORTADOR: IMPORTER’S NAME

GE HEALTHCARE DO BRASIL COMÉRCIO E SERVIÇOS PARA EQUIPAMENTOS MEDICOS-HOSPITALARES LTDA.

ENDEREÇO DO IMPORTADOR: IMPORTER’S ADDRESS

Av. Magalhães de Castro, 4800, Andar 11 Conj. 111 e 112, Andar 12 Conj. 121 e 122, Torre 3 - Cidade Jardim - CEP: 05676-120 - São Paulo/SP - Brasil

CNPJ:

00.029.372/0001-40

RESPONSÁVEL TÉCNICO: TECHNICAL RESPONSIBLE

Renata Bellentani Brandão - CRF/SP nº 36.198

TELEFONE: TELEPHONE

3004 2525 (Capitais e Regiões Metropolitanas) 0800 165 799 (Demais Localidades)

REGISTRO ANVISA N°: ANVISA REGISTRATION N°

80071260360

Authorized Representative in Kazakhstan General Electric Kazakhstan LLP Timiryazev St 28V, office 307 Almaty, 050040 Kazakhstan T +7 727 3560020

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Vivid S70N / S60N – User Manual FR092760-1EN 12

Directives The GE ultrasound product families are tested to meet all applicable requirements in relevant EU Directives and European/International standards. •

Council Directive 93/42/EEC concerning MDD (Medical Devices Directive): the CE label affixed to the product testifies compliance to this Directive. The location of the CE marking is specified in ‘Device labels’ on page 2-26.

•

Year of first CE mark: 2015

Classifications According to 93/42/EEC Medical Device Directive, this is a Class IIa Medical Device. The following classifications are in accordance with the IEC/ EN 60601-1: •

According to IEC/EN 60601-1, Equipment is Class I, with BF or CF Applied Parts.

Type of protection against electric shock: •

Class I Equipment

Degree of protection against electric shock: •

Type BF Applied part (for Probes marked with BF symbol)

•

Type CF Applied part (for ECG, and probes marked with CF symbol)

•

The ECG applied part is protected against defibrillation.

Continuous Operation System is IPX0. Footswitch is IPX8. Transducers are IPX7. ICE catheters are IPX8.

Class I Equipment EQUIPMENT in which protection against electric shock does not rely on BASIC INSULATION only, but also includes an earth ground. This additional safety precaution prevents exposed metal parts from becoming LIVE in the event of an insulation failure.

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Type BF Applied part TYPE BF APPLIED PART providing a specified degree of protection against electric shock with particular regard to allowable LEAKAGE CURRENT. Patient leakage current Normal condition

Single fault condition

d.c.

<10 microA

<50 microA

a.c.

<100 microA

<500 microA

Type CF Applied part TYPE CF APPLIED PART providing a degree of protection higher than that for Type BF Applied Part against electric shock particularly regarding allowable LEAKAGE CURRENT. Patient leakage current Normal condition

Single fault condition

d.c.

<10 microA

<50 microA

a.c.

<10 microA

<50 microA

Original Documentation The original document was written in English.

Software License Acknowledgements WindowBlinds™ OCX © Stardock ®

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Vivid S70N / S60N – User Manual FR092760-1EN 12

Table of Contents

Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-3 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Importer Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-4 Authorized Representative in Kazakhstan - - - - - - - - - - - - - - - - - - - - - - - i-4 Directives- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Class I Equipment- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-5 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Type CF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Original Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Software License Acknowledgements- - - - - - - - - - - - - - - - - - - - - - - - - - i-6

Table of Contents Chapter 1 - Introduction Overview Attention - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-2 Documentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Conventions used in this manual - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Indications for use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Prescription device - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7 Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7

Contact Information Contacting GE Ultrasound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Manufacturer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14

Chapter 2 - Safety Safety Precautions Precaution Levels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-2

Owner responsibility Notice against user modification- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-3

Acoustic output Definition of the acoustic output parameters - - - - - - - - - - - - - - - - - - - - 2-4 Acoustic output and display on the Vivid S70N / S60N - - - - - - - - - - - - - 2-5 ALARA - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Safety statement- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 System controls affecting acoustic output - - - - - - - - - - - - - - - - - - - - - - 2-8 OB Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10

Important safety considerations Patient safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-11 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-15

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Electromagnetic Compatibility (EMC) - - - - - - - - - - - - - - - - - - - - - - - - 2-19 Environmental protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-25

Device labels Symbols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-26 For China only - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-30

Chapter 3 - Prepare the System for Use Site requirements Power requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2 Operating Environment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Environmental requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Electromagnetic interferences - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Connecting the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4

System Overview Getting to know the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-9 Removable media- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-11 Physiological traces - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-14 Peripheral/accessory connector panel - - - - - - - - - - - - - - - - - - - - - - - 3-19 Wired Footswitch (Option) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-21

Switching On/Off Switch on the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-23 Log In - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-23 Switch off the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-24

Connect and disconnect probes Connect the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-26 Activate the probe- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-28 Deactivate the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30 Disconnect the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30 Intra Cardiac Ultrasound Catheters- - - - - - - - - - - - - - - - - - - - - - - - - - 3-31

The Scanning screen The Title bar- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-33 Parameters window - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34 Clipboard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34

Control panel Control Panel overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-35 Trackball area - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-37 Touch panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-38 The alphanumeric keyboard (option)- - - - - - - - - - - - - - - - - - - - - - - - - 3-42

Main display adjustment Lock/unlock the main display - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-44 Image Adjustment- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-45

Moving and transporting the system Wheels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48 Moving the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-48 Using Transportation mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-51 Transporting the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-52 Reinstalling at a new location- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-53 Preparing Vivid S70N / S60N for scanning - - - - - - - - - - - - - - - - - - - - 3-53

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Chapter 4 - Start an Examination Starting an examination Creating a new patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2 Selecting an existing patient record - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 Ending an examination - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3

Cineloop Cineloop overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-6 Using cineloop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-7

Zoom Display zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 HR zoom - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9

Annotations To insert an annotation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 Editing annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-12 To erase text annotations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Bodymark - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-13 Annotation and bodymark configuration - - - - - - - - - - - - - - - - - - - - - - 4-14

Chapter 5 - Image Optimization 2D-Mode 2D-Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Using 2D-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5 Optimizing 2D- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-5

M-Mode M-Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Using M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-9 Optimizing M-Mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-11

Color Mode Color 2D Mode overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-12 Color M-Mode overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-14 Using Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16 Optimizing Color Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-16

PW and CW Doppler PW and CW Doppler overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19 Using PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-21 Optimizing PW/CW Doppler modes - - - - - - - - - - - - - - - - - - - - - - - - - 5-21

Tissue Velocity Imaging (TVI) TVI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-23 Using TVI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25 Optimizing TVI - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-25

Tissue Tracking Tissue Tracking overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-26 Using Tissue Tracking- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28 Optimizing Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-28

Strain rate Strain rate overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29 Using Strain rate- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31 Optimizing Strain rate - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-31

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Strain Strain overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-32 Using Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34 Optimizing Strain - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34

Tissue Synchronization Imaging (TSI) TSI overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35 Using TSI- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-37

Contrast Imaging Data acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-39 Quantification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-44 Contrast Echocardiography Box - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-45

Additional scanning features LogiqView - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-46 Compound - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Virtual Convex - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 B-Flow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-47 Blood Flow Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-48

Image controls Control panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-49 Touch panel and rotaries - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-49

Scan Assist Pro Scan Assist Pro overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-59 Setting up Scan Assist Pro - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-61 Using Scan Assist Pro- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-63

Chapter 6 - 4D and Multi-plane Modes 4D-Mode Real-time, single beat 4D imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 Real-time, multi beat 4D imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2 4D-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 4D Color Flow mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14 Flexi-Slice - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-18 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20 4D-Mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-28

Multi-plane mode Bi-plane mode screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-35 Tri-plane mode screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-37 Using Multi-plane mode- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-39 Bi-plane prepare - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-39 Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-41 Multi-plane mode controls - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-43

FlexiViews

Chapter 7 - Stress Echo Introduction Selection of a stress test protocol template Image acquisition Starting acquisition - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5 Continuous capture mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-9

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Stress Echo analysis Image selection for analysis- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16 Wall motion scoring- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18

Quantitative TVI Stress echo analysis Accessing QTVI Stress analysis tools - - - - - - - - - - - - - - - - - - - - - - - - 7-22 Vpeak measurement - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-22 Tissue Tracking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 Quantitative analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 References - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25

Editing/creating a Stress Echo protocol template Entering the Template editor screen - - - - - - - - - - - - - - - - - - - - - - - - - 7-26 Editing/Creating a template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-27

Chapter 8 - Measurements and Analysis Introduction General recommendations about measurements - - - - - - - - - - - - - - - - - 8-4 About Measurement results display - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4

Assign and Measure modality Measure and Assign modality Measurements on volume renderings - - - - - - - - - - - - - - - - - - - - - - - - - 8-9

Measurements on protocol images Example results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-10

Advanced cardiac measurements and analysis Event timing measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11 TSI Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-12 Automated Function Imaging - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-18 Cardiac AutoDoppler- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-46 Pediatric Z-score measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-49

4D/Multi-plane LV 4D/multi-plane LV analysis tools- - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 4D Auto LVQ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-50 Manual left ventricular volume measurements - - - - - - - - - - - - - - - - - - 8-62 TSI surface model- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-67

4D Auto MVQ Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-69 Starting 4D Auto MVQ- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-70 Align Views - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-71 Set Landmarks - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-72 Review - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-74 Results - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-75 Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-77

4D Auto AVQ Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-78 Starting the 4D Auto AVQ tool - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-79 Slice alignment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-80 LVOT segmentation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-80 Measurements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-82 Approval - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-83

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Advanced vascular measurements and analysis Intima-Media Thickness- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-84 Vascular AutoDoppler - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-87

OB measurements OB graphs - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-89

Measurement result table Minimizing the Measurement result table - - - - - - - - - - - - - - - - - - - - - 8-95 Moving the Measurement result table - - - - - - - - - - - - - - - - - - - - - - - - 8-95 Deleting measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-95

Worksheet Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-96 Using the Worksheet- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-97

Measurement accuracy General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-99 Sources of error - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-99 Optimizing Measurement Accuracy - - - - - - - - - - - - - - - - - - - - - - - - 8-101 Measurement Uncertainties - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-101

Chapter 9 - Quantitative Analysis Introduction Q Analysis overview Starting Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-3 Q Analysis screen- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-4

Using Q Analysis Generation of a trace - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-9 Saving/retrieving Q Analysis - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-13 Frame disabling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-13 Optimization - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-15 Switching modes or traces- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-19 Anatomical M-Mode - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9-20

Chapter 10 - Archiving Introduction The dataflow concept Dataflows available - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3

Storing images and cineloops Storing an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-7 Storing a cineloop - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-8 Saving images and cineloops to a standard format - - - - - - - - - - - - - - 10-9 EZ DICOM CD Viewer- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-11

Retrieving and editing archived information Searching for a patient record - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-14 Editing data in the archive - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-17 Deleting archived information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-25 Moving examinations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-27

Review images in archive Review the images from a selected examination - - - - - - - - - - - - - - - 10-29 Review images from a selected patient record- - - - - - - - - - - - - - - - - 10-31

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Connectivity The dataflow concept - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-36 Dataflow selection- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-39

Transfer of patient records/examinations Transfer patient records/examinations between archives - - - - - - - - - 10-40 Transferring patient records/examinations- - - - - - - - - - - - - - - - - - - - 10-41

Disk management Configuring the Disk management function - - - - - - - - - - - - - - - - - - - 10-49 Running the Disk management function - - - - - - - - - - - - - - - - - - - - - 10-52

Data Backup and restore Backup procedure- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-57 Restore procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-61

Tricefy To register a Tricefy account - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-64 Configuration of Tricefy storage - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-65 TricefyPatientShare - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-66 Storing an exam in Tricefy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-68 Configuration of Tricefy QR - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-70

Data streaming Streaming in process - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-71

Chapter 11 - Report Introduction Creating a report Working with the report function To open a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-4 To choose another report template - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 To change patient information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 Images in the report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-6 To print a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-7 To store a report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-7 Retrieving an archived report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-8 Deleting an archived report - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-8

Structured Findings Prerequisite - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-9 Starting Structured Findings- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-10 Using Structured Findings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-12 Structured Findings configuration - - - - - - - - - - - - - - - - - - - - - - - - - - 11-14

Direct report Creating comments- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-25 Creating pre-defined text inputs - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-26

Report designer Accessing the Report designer- - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-27 Report designer overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-28 Designing a report template - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-30 Saving the report template- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-42 To exit the Report designer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-42

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Report templates management Configuration of the Template selection menu - - - - - - - - - - - - - - - - - 11-44 Export/Import of Report templates - - - - - - - - - - - - - - - - - - - - - - - - - 11-45

Chapter 12 - Customize Configuration Customize System Settings About system Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-2 General system settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-4

Touch Panel Shortcuts - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-6

Users and Security Local System Users - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-8 User Policies - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-11 LDAP- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-12 System password - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-14 Storage Encryption - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-15

Global imaging settings Global imaging settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-18

Measurement Package Basic operations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-19 Measurement package configuration - example - - - - - - - - - - - - - - - - 12-21 User-defined formulas - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-23 Advanced settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-31 Normal values - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-38 Transfer of user-defined measurements transfer in DICOM SR - - - - - 12-39 Advanced Quantification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-40

Connectivity configuration System in a network environment- - - - - - - - - - - - - - - - - - - - - - - - - - 12-42 System in a network environment with a DICOM server - - - - - - - - - - 12-43 Wireless Network Configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-54 Data Streaming - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-60

Archive Configuration of the archiving functions- - - - - - - - - - - - - - - - - - - - - - 12-64 TCP/IP configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-65 Dataflow - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-65 Default remote path setting - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-69 XML Export configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-70 Patient ID- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-71 Other - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-72

Scan Assist Pro Creator Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-75 Protocol export from Vivid S70N / S60N and off-system installation of the Scan Assist Pro Creator - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-75 Starting Scan Assist Pro Creator - - - - - - - - - - - - - - - - - - - - - - - - - - 12-77 File handling- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-78 Creating new Protocols - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-79 Saving Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-80 Views - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-81

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Step attributes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-83

Stress Echo Application Presets List Generating a new preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-90 Deleting an application preset - - - - - - - - - - - - - - - - - - - - - - - - - - - - 12-93

6VT-D TEE Probe

Chapter 13 - Probes Probe overview Supported probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-2 Probe presets- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-6 Maximum probe temperature - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-8 Probe orientation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-9 Probe labeling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-10 Intracardiac Ultrasound Catheters - - - - - - - - - - - - - - - - - - - - - - - - - 13-11

Care and Maintenance Planned maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-15 Inspecting the probe - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-15 Cleaning and disinfecting probes - - - - - - - - - - - - - - - - - - - - - - - - - - 13-17 Coupling gels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-42

Probe safety Electrical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-43 Mechanical hazards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-43 Biological hazards- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-44

Biopsy Biopsy capability for probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-46 Precaution concerning the use of biopsy procedures - - - - - - - - - - - - 13-47 Preparing the Biopsy guide attachment - Convex, Sector and Linear probes 13-47 Preparing the Biopsy guide attachment - endocavity probe - - - - - - - - 13-51 Displaying the Guide zone - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-52 Biopsy needle path verification- - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-53 Starting the biopsy procedure - - - - - - - - - - - - - - - - - - - - - - - - - - - - 13-53 Cleaning, disinfection and disposal- - - - - - - - - - - - - - - - - - - - - - - - - 13-53

Chapter 14 - Peripherals Introduction Printing To print an image - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-4

Printing configuration P1 button configuration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-5 Printer setup- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-6

Flexible Video Out Connect external monitor- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-8 Select region to show on the external monitor - - - - - - - - - - - - - - - - - - 14-9 Full Screen video out region - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-10 Image video out region - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-10

View-X TCP/IP Configuration for View-X - - - - - - - - - - - - - - - - - - - - - - - - - - 14-13

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View-X Direct - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-15 Adjust Cropping of the Video Stream - - - - - - - - - - - - - - - - - - - - - - - 14-17

CartoSound CartoSound/SoundStar - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 14-19

Chapter 15 - Maintenance System Care and Maintenance Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 Expected Service Life Description - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 Inspecting the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-2 Disinfection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3 Cleaning the system - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-3 Cleaning the probes - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-7 Prevention of static electricity interference- - - - - - - - - - - - - - - - - - - - - 15-7

System self-test System malfunction- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-8

Software update Software download and installation- - - - - - - - - - - - - - - - - - - - - - - - - 15-10 Save TCP/IP settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15-13

Index

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Vivid S70N / S60N – User Manual FR092760-1EN 12

Chapter 1 Introduction

The Vivid S70N / S60N is a high performance digital ultrasound imaging system with total data management. The system provides image generation in 4D (option on Vivid S70N), 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications. The fully digital architecture of the Vivid S70N / S60N system allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies. This chapter provides information concerning indications for use/contraindications, contact information, and how this documentation is organized.

Vivid S70N / S60N – User Manual FR092760-1EN 12

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Introduction

Overview

Attention This manual contains necessary and sufficient information to operate the ultrasound system safely. Read and understand all instructions in the User Manual before attempting to use the ultrasound system. Keep this manual with the equipment at all time. Periodically review the procedures for operation and safety precautions. Disregarding information on safety is considered abnormal use. Not all features or products described in this document may be available or cleared for sale in all markets. Please contact your local GE Healthcare representative to get the latest information.

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NOTE:

Please note that orders are based on the individually agreed upon specifications and may not contain all features listed in this manual.

NOTE:

All references to standards / regulations and their revisions are valid at the time of publication of the user manual.

Vivid S70N / S60N – User Manual FR092760-1EN 12